(69 days)
Not Found
No
The summary describes a standard electrosurgical device for coagulation and does not mention any AI or ML capabilities, image processing, or data-driven features.
No.
The device is used for coagulation of soft tissue during various surgical procedures, which is a surgical tool function, not a therapeutic one.
No.
Explanation: The device description explicitly states its purpose is for "grasping and general coagulation/cutting and pinpoint coagulation of tissue using electrosurgical energy." This indicates a therapeutic or surgical function, not a diagnostic one. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly states it is a "Micro-Bipolar Forceps Device," which is a physical instrument used for grasping and coagulation. It also mentions "reusable probes," further indicating a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is used for bipolar coagulation of soft tissue during surgery. This is a direct intervention on the patient's body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use is for surgical procedures to coagulate tissue, not to diagnose a condition based on laboratory analysis.
The device is an electrosurgical instrument used in vivo (within the living body) during surgical procedures.
N/A
Intended Use / Indications for Use
The Select-Sutter Micro-Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. This product is used with bipolar output of standard electrosurgical generators. The types of surgery intended are: General sugery Laparoscopic procedures Endoscopic procedures Laryngeal coagulation Orthopedic coagulation Thorascopic coagulation Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization) Ear, Nose and Throat coagulation
Product codes
GEI
Device Description
The Micro-Bipolar Forceps Device is a laparoscopic and endoscopic device used for the grasping and general coagulation/cutting and pinpoint coagulation of tissue using electrosurgical energy under visualization. The device is used with bipolar outputs of electrosurgical generators and has reusuable probes for grasping/coagulation and pinpoint coagulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, Laryngeal, Orthopedic, Thorascopic, Neurosurgical, Gynecological (except for female sterilization), Ear, Nose and Throat
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician familiar with electrosurgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
K992 760
DA 11
Select Medizin-Technik Hermann Sutter GmbH
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | Select Medizin-Technik Hermann Sutter GmbH
Tullastr, 87
79108 Freiburg, Germany
Tel: +49 (0) 761-51 551- 0
Fax: +49 (0) 761-51 551 - 30 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bert Sutter, Vice-President. Sales/Marketing and Product
Management |
| Date Prepared: | July 21, 1999 |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and
Accessories, Laparoscopic |
| Common/Usual Name: | Micro Bipolar Forceps |
| Proprietary Name: | Select-Sutter Micro-Bipolar Forceps |
| Predicate Device: | MiniSite® Bipolar Forceps, U.S. Surgical Corporation
(K972415) |
| Device Description: | The Micro-Bipolar Forceps Device is a laparoscopic and
endoscopic device used for the grasping and general
coagulation/cutting and pinpoint coagulation of tissue using
electrosurgical energy under visualization. The device is
used with bipolar outputs of electrosurgical generators and
has reusuable probes for grasping/coagulation and pinpoint
coagulation. |
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 1999
Select Medizin-Technik Hermann Sutter GmbH c/o Ms. Anita Thibeault Anita Thibeault & Associates 9070 Bluffview Trace Roswell, Georgia 30076
Re: K992760
Trade Name: Select-Sutter Micro-Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: August 12, 1999 Received: August 17, 1999
Dear Ms. Thibeault:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 -- Ms. Anita Thibeault
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
-Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Select Medizin-Technik Hermann Sutter GmbH
INDICATIONS FOR USE
The Select-Sutter Micro-Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. This product is used with bipolar output of standard electrosurgical generators. The types of surgery intended are:
General sugery Laparoscopic procedures Endoscopic procedures Laryngeal coagulation Orthopedic coagulation Thorascopic coagulation Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization) Ear, Nose and Throat coagulation
Paitella
vision Sien-Off) ivision of General Restorative Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)